Iovance Biotherapeutics, Inc.

Controller

• Provides strategic accounting, tax and investment leadership
• Manages and develops a high performing finance team to ensure effective operation of the function in carrying out needed initiatives
• Leads the Company’s financial close process, including preparation of financial statements and management reporting metrics and analysis in a timely manner
• Continually evaluates opportunities to drive greater efficiencies and effectiveness in the monthly and quarterly accounting close process while ensuring a balanced workload within the organization
• Responsible for external financial reporting process
• Evaluate current accounting practices, systems and policies to ensure practices and financial reporting are continuously improving, and meet current and future requirements
• Responsible for financial audits and provides recommendations for procedural improvements
• Ensure compliance with all SEC, GAAP, FASB rules and regulations in addition to state, local and corporate policies, regulations and laws
• Liaison with external independent auditors
• Responsible for Sarbanes-Oxley compliance
• Responsible for tax planning, analysis and compliance
• Responsible for Treasury functions including investments within policy while ensuring highest possible return on investment and liquidity for near term operations
• Collaborate closely with the legal team in regard to the Company’s governance processes, including leading the disclosure committee process
• Direct and manage all aspects the Company’s tax reporting function ensuring timely and accurate regulatory filings globally as well as ensuring an appropriate tax provision
• Ensures compliance with local, state, and federal budgetary and pricing reporting requirements, including Sunshine Act reporting
• Provides accounting and business expertise to corporate development transactions, including collaboration agreements
• Perform miscellaneous duties as assigned.

Senior Vice President, Global Corporate Controller

Analyst

• Supports all aspects of the Computer Systems Validation (CSV) Lifecycle.
• Creates documentation and executes implementation tasks while ensuring compliance with regulatory agencies.
• Generates CSV lifecycle documentation to meet ongoing requirements such as 21 CFR Part 11, EU Annex 11, and data integrity.
• Completes execution and documentation required per the CSV, including plans, risk assessments, user requirements, functional requirements, and validation reviews.
• Ensures project deadlines and performance standards are met while responding to inquiries from management, end users, and clients.
• Collaboratively works to deliver validated computer systems for internal clients.

Computer Systems Validation Analyst II

Executive Assistant

• Provides executive administrative and project support to the CFO
• Complex calendar management – coordinate and schedule meetings
• Prioritize inquiries and requests while troubleshooting conflicts
• Plan, manage and coordinate extensive and complex travel arrangements
• Administer correspondence, manage incoming calls, and prioritize phone messages, emails and mail
• Prepare and handle business expenses and reconciliations
• Maintain confidentiality and exercise high degree of discretion
• Make judgments and recommendations to ensure smooth day-to-day engagements
• Manages CDAs, contracts, and agreements with companies the CFO initiates/enters discussions
• In the CFO’s absence, ensure any requests for action or information are handled timely; interpret requests and implement action as needed
• Administration of press releases
• Respond to stockholder queries, set up analyst calls, and manage annual shareholder meetings
• Set up road shows, conferences, and other IR events
• Maintain and update corporate and IR contact databases
• Liaison to the BOD members and investor relations companies
• Create and manage annual other meetings calendar; coordinate and schedule meetings
• Prepare and distribute board materials and presentations
• Negotiate corporate rates with travel agents/companies/vendor
• Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

Director

• Report to the Executive Scientific Director, Medical Affairs.
• Represent Iovance Medical Affairs as needed, serving as a TIL cell therapy therapeutic area expert in educational, strategic, and tactical discussions/presentations with internal colleagues as well as external experts and investigators.
• Support field clinical activities and lead the development of impactful content for the Field Medical Team, including presentations, congress materials, and training modules.
• Engage and educate external HCP stakeholders.
• Support advisory board meetings and congress scientific forum planning.
• Collaborate with cross-functional teams to ensure the alignment of medical strategies with overarching corporate objectives.

Scientific Director, Medical Affairs

Manager

• Serve as a trusted and knowledgeable single point of contact for patients, caregivers, and healthcare providers through the IovanceCares call center, demonstrating exceptional communication and tele-management skills.
• Independently manage and take ownership of all patient cases, from patient registration through post-infusion within assigned geographic areas; and provide coverage for other case managers when necessary.
• Establish collaborative relationships with our partners at the ATCs. Consistently and considerately share information with sites and gather information to help Iovance better manage the patient journey.
• Triage all issues appropriately, use resources to aid sites, and follow-up to confirm that issues are resolved.
• Effectively collaborate with inter-disciplinary health care teams at treatment centers (e.g., Nurse Navigators, Financial and Billing Administrators, Patient Support and Access personnel, and Social Workers).
• Partner seamlessly with Iovance cross-functional teams to promptly deliver customer service and support to meet the needs of our patients, caregivers, and healthcare providers.
• Clearly and effectively communicate critical case-related information to patients, caregivers, and healthcare professionals to appropriately manage expectations.
• Complete all Case Manager training and demonstrate exceptional knowledge and seamless navigation of IovanceCares (i.e. case management system, customer portal, telephone system) and processes (i.e., SOPs, work instructions, business rules). The ability to quickly learn about new computer systems and be detail-oriented is essential in this role.
• Support Authorized Treatment Center launch activities as necessary (including site onboarding and Quarterly Business Reviews).
• Manage and contribute to continuous improvements and development of innovative solutions to deliver an enhanced patient care experience. Maintain current knowledge of and follow established IovanceCares objectives, processes, regulatory and compliance standards, policies, and procedures.
• Demonstrate genuine passion and care for patients and uphold Iovance values in daily individual work performance.
• Adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics.
• Perform miscellaneous duties as assigned.

Case Manager

Financial Planning and Analysis

• Analyzing actual operating costs and developing forecasts
• Reviewing Purchase Orders for contracts and SOWs
• Comparing contract payments to budget
• Recommending cost-efficient options
• Incorporating the 3PL reports into internal financial reporting
• Providing financial reporting back to management
• Developing and maintaining forecasting models
• Compiling data on expenses and costs
• Supporting internal and external financial audits

Senior Analyst, Financial Planning & Analysis

Research Analyst

• Independently manages the study start up activities for multi-center, US and/or global based studies.
• Performs on-site visits (feasibility, SIV, IMV, Close-Out) with CRO CRAs as needed to assess the sites’ and CRA’s overall performance.
• Provides monitoring oversight by reviewing monitoring schedules, metrics and reports.
• Responsible for the clinical site training and sites adherence to protocol, all applicable GCP/ICH guidelines, regulations statutes and SOPs.
• Leads or participates in vendor management activities (e.g., Central Laboratory, Central Imaging, CRO).
• Performs in-house routine data listings review.
• Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out.
• Supports CTM and cross-functional representatives as required in relationship management tasks (e.g., contracts, study logistics, patient enrollment, safety, data management, etc.) to accurately coordinate clinical study activities.
• Mentors and coaches’ junior staff new to Clinical Research (e.g. Clinical Trial Assistants).
• Assists with the development of protocol writing, informed consent development, CRFs, monitoring conventions, tracking forms, and other study related documents.
• Assists in managing and/or leading the day-to-day operations of assigned studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
• Performs other duties and assignments as required for the overall success of the projects.

Senior Clinical Research Associate

Software Engineer

• Oversee the work of direct reports to ensure on-time, on-target and within-budget results.
• Maintain communication with data management and clinical operations.
• Exercise independent judgment in developing methods, techniques and evaluation criteria.
• Design, develop, evaluate and modify computer programs to analyze and evaluate clinical data.
• Oversee and manage workflow for study-specific and ad-hoc clinical data listings, summary tables and figures.
• Determine methods and procedures on new assignments.
• Perform data analysis primarily using SAS for summary and interpretation of clinical trial data.
• Manage creation of CDISC SDTM and ADaM files, SAS export files, and Define.xml for electronic submission.
• Manage data analysis and statistical analysis; generate safety and efficacy tables, listings and graphs using Base SAS, SAS Macros, SAS/STAT, SAS/Graph, SAS/SQL and SAS/ODS.
• Review Data Management Plan, Data validation plan and edit check specifications.
• Interact with statisticians and clinical team; perform ad hoc analysis and generate outputs per requirements.
• Implement and contribute to statistical analysis plans; provide expertise related to protocol development, CRF design and data collection.
• Identify and initiate resolution of data inconsistencies and quality issues.
• Manage development of SAS coding and table templates; create tools to improve programming efficiency and quality.
• Establish monitoring of data transfers for ongoing trials to identify study conduct or data quality issues.
• Adhere to company core values, policies, procedures, business ethics and safety SOPs; perform miscellaneous duties as assigned.

Programmer

• Partner with the CFO and executive leadership to drive financial strategy, long-range planning, scenario modeling, and enterprise risk management.
• Lead global FP&A covering Clinical, Commercial, Manufacturing, Supply Chain finance, and COGS strategy; oversee forecasting, budgeting, reporting, and variance analysis.
• Provide strategic commercial finance support: forecasting, pricing strategy, promotional effectiveness, ROI analysis, and launch planning for new products and indications.
• Oversee manufacturing and supply chain finance: product costing methodologies, inventory controls, cost optimization, capital investment evaluation, and gross margin management.
• Deliver timely dashboards and Board materials; support public company activities including earnings preparation, investor relations input, and financial disclosures.
• Evaluate business development opportunities (M&A, partnerships, licensing) from a financial perspective and support Board and Audit Committee reporting.
• Build, lead, and mentor a high-performing global finance team; foster financial discipline, innovation, accountability, and transparency.
• Represent company finance to external auditors, investors, and analysts as needed; optimize finance systems, tools, and processes to scale with growth.
• Travel to various sites (Philadelphia, San Carlos, Tampa) as needed and operate within a remote or professional workplace environment.

Senior Vice President, Finance – Global Strategy and Planning

Compliance

• Leads the development and implementation of all CMC regulatory strategy to support global development programs and market applications for cell therapies
• Responsible for ensuring the appropriate execution of CMC regulatory strategy
• Provide strategic and operational leadership and ensure effectiveness of the CMC Regulatory Affairs team
• Lead preparation of CMC-related submission planning, risk assessments, and ensure high-quality, accurate submission documents completed within target timelines
• Build and manage relationships with internal and external stakeholders and work across functions
• Ensure CMC dossiers meet ICH format and local country requirements; stay current with regulatory requirements and initiate process improvements
• Analyze complex CMC issues, interpret and discuss data with cross-functional teams and health authorities

Vice President, CMC Regulatory Affairs

Project Manager

• Manage the Process and Analytical Development project portfolio, tracking timelines, contracts, and deliverables.
• Create, establish, and maintain comprehensive project plans and timelines in collaboration with cross-functional teams.
• Drive effort to create project management processes, best practices, tools and dashboards for cross-functional projects.
• Ensure understanding and adherence to internal and external governance processes.
• Identify critical path and at-risk activities, anticipate bottlenecks, and help clear barriers to progress.
• Build productive internal and external working relationships with cross-functional teams.
• Prepare solid presentation materials for project progress, status, and dashboard reports.
• Identify and initiate process improvements and perform miscellaneous duties as assigned.

Accountant

• Perform day-to-day, monthly, and quarterly administration tasks such as customer aging reports, collection communications, and account reviews with third-party logistics provider.
• Support and collaborate with banking/cash accounting team to reconcile customer payments.
• Ensure timeliness and accuracy of order-to-cash activity in the ERP system, NetSuite, including invoicing and any related adjustments, such as credit memos.
• Manage product revenue AR to ensure timely collection of customer invoices and prompt dispute resolution; act as the primary point of escalation and work with internal departments and customers to drive problem resolution.
• Customer maintenance activities including new customer set-up and credit limits.
• Liaison with third-party logistics provider for transactions including accounts receivable, sales, returns, and chargebacks.
• Ensure timely and accurate accounting close related to order to cash, including accounts receivable, product revenue, gross-to-net revenue.
• Prepare month-end close journal entries and reconciliations for sales revenue, accounts receivable, gross-to-net payments, and royalty revenue.
• Maintain and reconcile data files used to support month end close activities and dashboard presentations.
• Execute SOX controls and support internal and external audits.
• Demonstrate strong knowledge of US GAAP and perform financial analysis, reporting and interpretation of data.
• Additional duties as needed.